Impact of Gamma-OH on sleep in ICU patients difficult to wean from mechanical ventilation

CHU de Poitiers0 个研究点目标入组 20 人开始时间: 2019年9月30日最近更新: 2024年1月8日

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•Patients intubated at least 24 hours in the intensive care unit and difficult to wean from mechanical ventilation according to international guidelines, i.e. who failed at least one spontaneous breathing trial.
•Age = 18 years
•Patients will be included after to obtain inform consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•Patients with underlying neuromuscular disease (Myopathy or myasthenia gravis), or with central nervous disease (cancer, stroke, hemorrhage, Parkinson, seizures, multiple sclerosis….) or known psychiatric disease that may modify analysis of sleep recordings on polysomnography.
•Patients with severe obesity (BMI 40 kg/m2) will be excluded to avoid under/overdose.
•Contraindication to Gamma-OH®: hypersensitivity to the active substance or to any of the excipients, severe hypertension, bradycardia due to disorders of intracardiac conduction, uncorrected hypokalaemia, major depression, epilepsy, eclampsia, alcoholism, porphyria ,
•Patients participating in another category 1 study, sleep assessment study, or study evaluating extubation

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